A Phase 1 interventional study of ([18F]-DOPA) and ([18F]-6F-DA) in Pheochromocytoma, Endocrine Disease and Endocrine Diseases, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Recruiting at 1 site in United States. Open to participants aged 3 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Phase 1, Interventional, and Diagnostic
Among 69 studies in Pheochromocytoma with a site in United States — 21 open to participants now, 30 under way, none of them phase 3. Pheochromocytoma · United States.
Among the 69 studies in Pheochromocytoma with a site in United States, this one has the largest planned enrollment of the 52 interventional ones, is one of 2 that started in 2000, is one of 13 in phase 1, reaches primary completion later than 25 of the 25 other live ones, and was the 5th registered.
158 studies on the registry are indexed under Pheochromocytoma; 57 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 37 across 87 interventional studies indexed under Pheochromocytoma.
Browse Pheochromocytoma studies →21 of the 69 studies in Pheochromocytoma with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 43 Pheochromocytoma studies recruiting now, 22 (51%) set no upper age limit and 6 (14%) stop at 75 or younger; 19 take children under 18; 4 take healthy volunteers.
This study: 3 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →69 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 2 started in 2000.
Median enrollment 31 across the 52 interventional studies, 370 across the 10 observational. Of the 30 that completed or were terminated, 13 (43%) have results posted.
14 of 69 have an industry lead sponsor. The 10 most frequent:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has 2 studies filed under Pheochromocytoma — fewer than ten, so there is no comparison to draw.
7 of the studies in Pheochromocytoma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05636540Heather WachtelIn Vivo PARP-1 Expression With 18F-FluorThanatrace PET/CT in Patients With Pheochromocytoma and Paraganglioma | 2026-12-31 |
| NCT03839498Columbia UniversityStudy of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma | 2027-01 |
| NCT03541720St. Jude Children's Research Hospital18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma | 2027-01-01 |
| NCT03946527Antonio FojoLAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA) | 2027-03 |
| NCT00107289Memorial Sloan Kettering Cancer CenterIodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma | 2027-05 |
Among the 69 studies in Pheochromocytoma with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
The goal of this study is to develop better methods of diagnosis, localization, and treatment for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often difficult to detect with current methods. Pheochromocytomas release chemicals called catecholamines, causing high blood pressure. Undetected, the tumors can lead to severe medical consequences, including stroke, heart attack and sudden death, in situations that would normally pose little or no risk, such as surgery, general anesthesia or childbirth.
Patients with pheochromocytoma may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. Study participants will undergo blood, urine, and imaging tests, described below, to detect pheochromocytoma. If a tumor is found, the patient will be offered surgery. If surgery is not feasible (for example, if there are multiple tumors that cannot be removed), evaluations will continue in follow-up visits. If the tumor cannot be found, the patient will be offered medical treatment and efforts to detect the tumor will continue. Main diagnostic and research tests may include the following:
Pheochromocytomas (PHEOs) and paragangliomas (PGLs) are rare and clinically important chromaffin cell tumors that typically arise from the adrenal gland or from extra-adrenal paraganglia, respectively. The clinical features and consequences of PHEO/PGL result from the release of catecholamines (norepinephrine and/or epinephrine). An undetected PHEO/PGL poses a hazard to patients undergoing surgery, childbirth, or general anesthesia, due to the potential for excess catecholamine secretion, which can result in significant, often catastrophic outcomes. Diagnosing and localizing a PHEO/PGL can be challenging. Plasma and urinary catecholamines as well as their metabolites and radio-iodinated metaiodobenzylguanidine (MIBG) scanning can yield false-positive/negative results in patients harboring the tumor. Computed tomography (CT) and magnetic resonance imaging (MRI) lack sufficient specificity. The molecular mechanisms by which genotypic changes predispose to the development of PHEO/PGL remain unknown - even in patients with identified pathogenic variants. Moreover, in patients with hereditary predispositions, PHEOs/PGLs differ in terms of their growth, malignant potential, catecholamine phenotype, responses to standard screening tests, various imaging modalities and therefore subsequently, different therapeutic options. This protocol focuses on developmental, molecular, genetic, epigenetic, proteomic, metabolomics, immunologic and other types of studies to investigate the bases for predisposition to develop PHEOs/PGLs and for expression of different neurochemical and other phenotypes and malignant potentials including therapeutic responses. Furthermore, this protocol will also use new imaging approaches, for example [18F]-6F-dopamine ([18F]-6F-DA), and [18F]-L-3,4-dihydroxyphenylalanine ([18F]-FDOPA) positron emission tomography (PET)/CT, as well as dynamic contrast-enhanced MRI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients are eligible for inclusion in this study if they are adults or children of age 3 years old and up with known, sporadic or familial PHEO/PGL, on the basis of one or more of the following:
Signed is required. The informed consent may be signed by the patient, parent/guardian in pediatric patients or legally authorized representative (LAR) in adults who lack-decision making capacity to consent to research participation.
Patients must have an outside general practitioner or endocrinologist. Patients with disease must also have an outside oncologist.
Family Members of Patients Arm (Linkage Analysis)
Participants are eligible for inclusion in this study arm if they are:
EXCLUSION CRITERIA:
Potential patients will be excluded on the basis of one or more of the following:
A pregnancy test is performed in women of childbearing age (up to age 55) as a screening after consenting. If a patient is found to have a positive pregnancy test, her participation in this protocol will be terminated. The patient can enroll or re-enroll in the protocol when she is no longer pregnant or breastfeeding.
In-person participating patients who are not willing to return to the NIH (e.g., after surgery or an initial evaluation) for more than 2 years may be removed from the protocol.
SPECIFIC INCLUSION/EXCLUSION CRITERIA FOR IMAGING STUDIES WITHIN OUR PROTOCOL:
In adult patients (Excludes Linkage Analysis Arm)
Imaging studies are not done in patients that have the following exclusion criteria:
In pediatric patients:
Inclusion criteria for research PET imaging in children:
Children over 10 years old with very high suspicion of sporadic or familial PHEO/PGL based on at least one of the following:
Exclusion criteria for research PET imaging in children:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are adults or children of any age with known, sporadic or familial PHEO/PGL
Drug: ([18F]-DOPA) · Drug: ([18F]-6F-DA)
is L 3, 4 dihydroxyphenylalanine (L-DOPA) labeled with the radioactive isotope 18F. In general, PPGLs belong to the group of neuroendocrine tumors. This heterogeneous group of tumors takes up amino acids, transforms them into biogenic amines (dopamine and serotonin) by decarboxylation and stores the amines in vesicles. L DOPA is a precursor of catecholamines (dopamine, norepinephrine and epinephrine). Epinephrine conversion to dopamine is catalyzed by the aromatic amino acid decarboxylase. According to previous and current studies, \[18F\]-DOPA PET is highly sensitive and specific for detection of PHEO/PGL67-69. However, there are only a few reports in the literature using \[18F\]-DOPA as a PET agent and particularly for patients with metastatic PPGLs. PET imaging will be done together with either a CT, an MRI or both modalities.
is an imaging agent developed at the NIH, that may improve specificity and sensitivity in the localization of PPGLs. \[18F\]-6F-DA enters cells via the membrane norepinephrine transporter. Once inside cells, \[18F\]-6F-DA is translocated via the vesicular monoamine transporter into storage vesicles, where the radioactivity is concentrated. After injection of \[18F\]-6F-DA, the much faster disappearance of \[18F\]-6F-DA-derived radioactivity from the bloodstream and non-neuronal cells than from chromaffin cells should enable rapid visualization of PPGLs by PET scanning.
To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas.To stuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell ...
To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas.To stuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell lines, animal
Time frame: Baseline
To educate health care professionals and patients about pheochromocytoma and paraganglioma
To educate health care professionals and patients about pheochromocytoma and paraganglioma
Time frame: end of study
Started Mar 2000 (actual). Primary completion is estimated for Nov 2048, 584 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) →